Pivoting Compensating Filters for the Head
FDA 510(k) K972766 · Octostop, Inc.
510(k) numberK972766
Submission
- Device name
- Pivoting Compensating Filters for the Head
- Applicant
- Octostop, Inc.
Montreal, Qc., CA - Received
- July 24, 1997
- Decision date
- August 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K963941 | The Pharaoh Compensating FilterKPR · Traditional | 11/27/1996SE |
| K953246 | OctorollKXH · Traditional | 09/29/1995SE |
| K952871 | Ridges PlusKPR · Traditional | 07/20/1995SE |
| K942916 | Octopaque UniversalIXQ · Traditional | 09/08/1994SE |
| K940306 | Octostop Compensating FiltersKPR · Traditional | 09/06/1994SE |
| K935444 | Octostop(R) Chair (New ModelIXR · Traditional | 09/02/1994SE |
| K930124 | Variant of Octostop and OctopaqueKXH · Traditional | 02/09/1994SE |
| K930357 | Accessory to Universal OctopaqueKXH · Traditional | 07/13/1993SE |
| K926069 | Wrist TractionKPR · Traditional | 01/21/1993SE |
| K913711 | Gentle SlopeKPR · Traditional | 10/14/1992SE |
Questions and answers
When was Pivoting Compensating Filters for the Head cleared by the FDA?
Pivoting Compensating Filters for the Head (K972766) received a 510(k) decision of Substantially Equivalent on August 14, 1997, 21 days after the submission was received.
What is the product code of K972766?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.